卵圆孔未闭封堵器材料研究进展Research progress on materials of patent foramen ovale occlader
周广泰,周超,张海军
摘要(Abstract):
卵圆孔未闭(PFO)是心源性脑卒中的重要危险因素,随着心脏介入技术的快速发展,PFO封堵器已成为治疗PFO的首选方法。封堵器材料的生物相容性、机械稳定性及其与患者解剖结构的适应性是决定治疗效果的关键因素,其研究取得了显著进展,早期封堵器主要采用金属材质,虽具有较高的封堵效果和操作便捷性,但存在长期留存体内的潜在风险。近年来,生物可降解材料在封堵器领域得到广泛应用,这类封堵器采用生物医用高分子材料制成,置入人体后起到临时桥梁作用,引导自体组织生物修复,并逐步降解为无害物质排出体外,避免了金属封堵器的长期留存问题。本文综述了PFO封堵器材料的研究进展,包括不可降解材料和生物可降解材料的应用,并探讨了当前研究的局限性和未来可能的发展趋势,为临床应用提供参考。
关键词(KeyWords): 卵圆孔未闭封堵器;不可降解材料;生物可降解材料
基金项目(Foundation): 国家自然科学基金项目(82270535)
作者(Author): 周广泰,周超,张海军
参考文献(References):
- [1]娄宇轩,华杨,张浩,等.卵圆孔未闭封堵器研究进展[J].中国心血管杂志,2022,27(5):495-498.DOI:10.3969/j.issn.1007-5410.2022.05.019.
- [2]Shi F,Sha L,Li H,et al.Recent progress in patent foramen ovale and related neurological diseases:a narrative review[J].Front Neurol,2023,14:1129062.DOI:10.3389/fneur.2023.1129062.
- [3]国家心血管病中心,中国心血管健康与疾病报告编写组,胡盛寿.中国心血管健康与疾病报告2023概要[J].中国循环杂志,2024,39(7):625-660.DOI:10.3969/j.issn.1000-3614.2024.07.001.
- [4]张玉顺,蒋世良,朱鲜阳.卵圆孔未闭相关卒中预防中国专家指南[J].心脏杂志,2021,33(1):1-10.DOI:10.12125/j.chj.202101022.
- [5]李爱敏,何建新,张迎,等.Memo Sorb~?生物可降解封堵器卵圆孔未闭封堵术后近期疗效观察1例[J].中国介入心脏病学杂志,2024,32(3):168-171.DOI:10.3969/j.issn.1004-8812.2024.03.008.
- [6]邱林,朱航,马为,等.卵圆孔未闭相关疾病研究2023年度进展[J].中国介入心脏病学杂志,2024,32(1):9-13.DOI:10.3969/j.issn.1004-8812.2024.01.003.
- [7]何璐,张玉顺.封堵卵圆孔未闭预防卒中的国外发展及中国现状[J].协和医学杂志,2021,12(3):318-321.DOI:10.12290/xhyxzz.2021-0136.
- [8]Mas JL,Derumeaux G,Guillon B,et al.Patent foramen ovale closure or anticoagulation vs.antiplatelets after stroke[J].N Engl J Med,2017,377(11):1011-1021.DOI:10.1056/NEJMoa1705915.
- [9]S?ndergaard L,Kasner SE,Rhodes JF,et al.Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke[J].N Engl J Med,2017,377(11):1033-1042.DOI:10.1056/NEJMoa1707404.
- [10]Saver JL,Carroll JD,Thaler DE,et al.Long-term outcomes of patent foramen ovale closure or medical therapy after stroke[J].N Engl J Med,2017,377(11)1022-1032.DOI:10.1056/NEJMoa1610057.
- [11]Lee PH,Song JK,Kim JS,et al.Cryptogenic stroke and high-risk patent foramen ovale:the DEFENSE-PFO trial[J].J Am CollCardiol,2018,71(20):2335-2342.DOI:10.1016/j.jacc.2018.02.046.
- [12]Morgan G,Lee KJ,Chaturvedi R,et al.A biodegradable device(Bio STAR~(TM))for atrial septal defect closure in children[J].Catheter Cardiovasc Interv,2010,76(2):241-245.DOI:10.1002/ccd.22517.
- [13]Happel CM,Laser KT,Sigler M,et al.Single center experience:implantation failures,early,and late complications after implantation of a partially Biodegradable ASD/PFO-device(BioSTAR~?)[J].Catheter Cardiovasc Interv,2015,85(6):990-997.DOI:10.1002/ccd.25783.
- [14]Shi D,Kang Y,Zhang G,et al.Biodegradable atrial septal defect occluder:a current review[J].Acta Bio mater,2019,96:68-80.DOI:10.1016/j.actbio.2019.05.073.
- [15]闫一鸣,欧阳文斌,张凤文,等.中国先天性心脏病介入治疗现状与展望[J].中国胸心血管外科临床杂志,2022,29(10):1243-1253.DOI:10.7507/1007-4848.202205081.
- [16]Lin C,Liu L,Liu Y,et al.Recent developments in nextgeneration occlusion devices[J].Acta Bio mater,2021,128:100-119.DOI:10.1016/j.actbio.2021.04.050.
- [17]Edwards-Lehr T,Franke J,Bertog SC,et al.Safety and performance of the spider patent foramen ovale occluder[J].Catheter Cardiovasc Interv,2013,81(2):317-323.DOI:10.1002/ccd.24584.
- [18]Testa L,Popolo Rubbio A,Squillace M,et al.Patent foramen ovale occlusion with the Cocoon PFO Occluder.The PROS-IT collaborative project[J].Front Cardiovasc Med,2023,9:1064026.DOI:10.338 9/fcvm.2022.1064026.
- [19]Thanopoulos BVD,Bompotis GC,Deleanou D,et al.Transcatheter closure of patent foramen ovale using the Cocoon occluder:a multicenter retrospective study[J].Hellenic J Cardiol,2024,75:21-25.DOI:10.1016/j.hjc.2023.04.011.
- [20]Apostolopoulou SC,Tsoutsinos A,Laskari C,et al.Largesingle centre experience with the Cera~(TM)and CeraFlex~(TM)occluders for closure of interatrial communications:usefulness of the flexible rotation feature[J].Cardiovase Interv Ther,2018,33(1):70-76.DOI:10.1007/s12928-016-0440-y.
- [21]Weglarz P,Wegiel M,Konarska-Kuszewska E,et al.Experience in patent foramen ovale closure with the CERA Lifetech occluder in patients with cryptogenic stroke[J].Postepy Kardiol Interwencyjnej,2023,19(3):257-261.DOI:10.5114/aic.2023.131479.
- [22]Sievert K,Yu J,Bertog S,et al.Post-market clinical fol-low-up with the patent foramen ovale closure device IrisFIT(Lifetech)in patients with stroke,transient ischemic attack or other thromboembolic events[J].Cardiovase Revasc Med,2021,30:72-75.DOI:10.1016/j.carrev.2020.09.031.
- [23]Sigler M,Soderberg B,Schmitt B,et al.Carag bioresorbable septal occluder(CBSO):histopathology of experimental implants[J].EuroIntervention,2018,13(14):1655-1661.DOI:10.4244/eij-d-17-00006.
- [24]Araszkiewicz A,Sawek S,Trojnarska O,et al.Interventional closure of patent foramen ovale with Nit-Occlud device in prevention of recurrent neurologic events—Long-term results[J].Catheter Cardiovasc Interv,2018,92(1):159-164.DOI:10.1002/ccd.27386.
- [25]Trabattoni D,Gili S,Calligaris G,et al.Piero Montorsi Patent foramen ovale clo sure with the Occlutech Figulla FlexⅡdevice:a long-term(up to 10-years)follow-up[J].Int J Cardiol,2023,387:131116.DOI:10.1016/j.ijcard.2023.06.007.
- [26]Pioch N,Trabattoni D,Bouvaist H,et al.The RISE study:retrospective registry for the international safety and efficacy results of patent foramen ovale closurewith Figulla FlexⅡPFO and UNI Occluders[J].J Clin Med,2024,13(6):1681.DOI.org/10.3390/jcm13061681.
- [27]Roina Y,Auber F,Hocquet D,et al.ePTFE-based biomedical devices:an overview of surgical efficiency[J].J Biomed Mater Res B Appl Biomater,2022,110(2):302-320.DOI:10.1002/jbm.b.34928.
- [28]Hardt SE,Eicken A,Berger F,et al.Closure of patent foramen ovale defects using GORE~?CARDIOFORM septal occluder:results from a prospective European multicenter study[J].Catheter Cardiovasc Interv,2017,90(5):824-829.DOI:10.1002/ccd.26993.
- [29]Nour S,Baheiraei N,Imani R,et al.A review of accelerated wound healing approaches:biomaterial-assisted tissue remodeling[J].J Mater Sci Mater Med,2019,30(10):120.DOI:10.1007/s10856-019-6319-6.
- [30]Xie ZF,Wang SS,Zhang ZW,et al.A novel-design polyL-lactic acid biodegradable device for closure of atrial septal defect:long-term results in swine[J].Cardiology,2016,135(3):179-187.DOI:10.1159/000446313.
- [31]Lu W,Ouyang W,Wang S,et al.A novel totally biodegradable device for effective atrial septal defect closure:a 2-year study in sheep[J].J Interv Cardiol,2018,31(6):841-848.DOI:10.1111/joic.12550.
- [32]Li Y,Xie Y,Li B,et al.Initial clinical experience with the biodegradable Absnow~(TM)device for percutaneous closure of atrial septal defect:a 3-year follow-up[J].J Interv Cardiol,2021,2021:6369493.DOI:10.115 5/2021/6369493.
- [33]Deeken CR,Chen DC,Lopez-Cano M,et al.Fully resorbable poly-4-hydroxybutyrate(P4HB)mesh for soft tissue repair and reconstruction:a scoping review[J].Front Surg,2023,10:1157661.DOI:10.3389/fsurg.2023.1157661.
- [34]Dong X,Premaratne ID,Sariibrahimoglu K,et al.3D-printed poly-4-hydroxybutyrate bioabsorbable scaffolds for nipple reconstruction[J].Acta Biomater,2022,143:333-343.DOI:10.1016/j.actbio.2022.02.040.
- [35]Alapati S,Rao PS.Historical aspects of transcatheter occlusion of atrial septal defects[M]//Rao PS.Atrial Septal Defect.Rijeka:IntechOpen,2012:57-84.
- [36]Du Y,Xie H,Shao H,et al.A prospective,single-center,phaseⅠclinical trial to evaluate the value of transesophageal echocardiography in the closure of patent foramen ovale with a novel biodegradable occluder[J].Front Cardiovasc Med,2022,9:849459.DOI:10.3389/fcvm.2022.849459.
- [37]Song L,Shi P,Zheng X,et al.Echocardiographic characteristics of transcatheter clo sure of patent foramen ovale with mallow biodegradable occluder:a single-center,phaseⅢclinical study[J].Front Cardiovasc Med,2022,9:945275.DOI:10.3389/fcvm.2022.945275.
- [38]Guo G,Hu J,Wang F,et al.A fully degradable transcatheter ventricular septal defect occluder:towards rapid occlusion andpostregeneration absorption[J].Biomaterials,2022,291:121909.DOI:10.1016/j.biomaterials.2022.121909.
- [39]Li Z,Kong P,Liu X,et al.A fully biodegradable polydioxanone occluder for ventricle septal defect closure[J].Bioact Mater,2022,24:252-262.DOI:10.1016/j.bioactmat.2022.12.018.
- [40]Liu SJ,Peng KM,Hsiao CY,et al.Novel biodegradable polycaprolactone occlusion device combining nanofibrous PLGA/collagen membrane for closure of atrial septal defect(ASD)[J].Ann Biomed Eng,2011,39(11):2759-2766.DOI:10.1007/s1043 9-011-0368-4.
- [41]Sievert K,Bertog S,S?derberg B,et al.Transcatheter closure of atrial septal defect and patent foramen ovale with Carag bioresorbable septal occluder:first-in-man experience with24-month follow-up[J].EuroIntervention,2022,17(18):1536-1537.DOI:10.4244/eij-d-21-00740.
- [42]Bayat G,Fallah-Darrehchi M,Zahedi P,et al.Kiwi extractincorporated poly(ε-caprolacto-ne)/cellulose acetate blend nanofibers for healing acceleration of burn wounds[J].J Biomater Sci Polym Ed,2023,34(1):72-88.DOI:10.1080/09205063.2022:2110483.
- [43]Homaeigohar S,Boccaccini AR.Nature-derived and synthetic additives to poly(ε-Caprolactone)nanofibrous systems for biomedicine;an updated overview[J].Front Chem,2022,9:809676.DOI:10.3389/fchem.2021.809676.
- [44]Duong-Hong D,Tang YD,Wu W,et al.Fully biodegradable septal defect occluder-a double umbrella design[J].Catheter Cardiovasc Interv,2010,76(5):711-718.DOI:10.1002/ccd.22735.
- [45]Wu W,Yip J,Tang YD,et al.A novel biodegradable septal defect occluder:the"Chinese Lantern"design,proof of concept[J].Innovations(Phila),2011,6(4):221-230.DOI:10.1097/imi.0b013e31822a2c42.
- [46]Pavcnik D,Takulve K,Uchida BT,et al.Biodisk:a new device for closure of patent foramen ovale:a feasibility study in swine[J].Catheter Cardiovasc Interv,2010,75(6):861-867.DOI:10.1002/ccd.22429.
- [47]Pavcnik D,Tekulve K,Uchida BT,et al.Double BioDisk:a new biopro sthetic device for transcatheter closure of atrial septal defects-a feasibility study in adult sheep[J].Radiol Oncol,2012,46(2):89-96.DOI:10.2478/v10019-012-0029-8.
- [48]Matsuzaki Y,Berman DP.Kurobe H,et al.Pre-clinical evolution of a novel transcatheter Bioabsorbable ASD/PFO occluder device[J].Pediatr Cardiol,2022,43(5):986-994.DOI:10.1007/s00246-021-02809-5.
- [49]Xiang Z,Zhang J,Zhou C,et al.Near-infrared remotely controllable shape memory biodegradable occluder based on poly(L-lactide-co-ε-caprolactone)/gold nanorod composite[J].ACS Appl Mater Interfaces,2023,15(36):42341-42353.DOI:10.1021/acsami.3c09852.
- [50]Mohammadi Nasr S,Rabiee N,Hajebi S,et al.Biodegradable nanopolymers in cardiac tissue engineering:from concept towards nano medicine[J].Int J Nano medicine,2020,15:4205-4224.DOI:10.2147/ijn.s245936.
- [51]张长东,李庚,钟禹成,等.2023年先天性心脏病介入治疗年度报告[J].中华心脏与心律电子杂志,2024,12(2):72-78.DOI:10.3877/cma.j.issn.2095-6568.2024.02.002.